NDC 67046-1230
Atorvastatin Calcium 20 mg tablet, film coated
On the label: Coupler LLC. It's repackaged: Coupler LLC rebottles it from Biocon Pharma Inc.'s NDC 70377-078.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Biocon Pharma Limited | Bengaluru, India | Makes it, tests it and packages it | No problems foundJun 2, 2023 · 1 inspection |
| Neolpharma, Inc. | Caguas, PR, United States | Makes it | Problems found, fixed voluntarilyMar 10, 2026 · 6 inspections |
| Recipharm Pharmaservices Private Limited | Bengaluru, India | Makes it | No problems foundMar 22, 2024 · 6 inspections |
Repackaging site
- Coupler LLC, West Chester, PA, United States · repackages it
Recalls
- Mar 17, 2025 · Class II · Biocon Pharma Inc
Failed dissolution specifications: lower than specifications
Lots: Lot#: AVC24035, Exp 03/31/26
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Atorvastatin: every company that makes it
- Form
- tablet, film coated
- Strength
- 20 mg
- Approval
- ANDA ANDA216436
- On the market since
- Nov 4, 2024
- Package NDCs
67046-1230-3- Official label
- DailyMed (National Library of Medicine), updated Nov 4, 2024
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